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Amend HB 2292, on third reading, by striking page 81, line 22
through page 83, line 17 and substituting the following and
relettering accordingly:
(c) For purposes of this section, the term "supplemental
rebates" shall mean cash rebates paid by a pharmaceutical
manufacturer to the State on the basis of quarterly Medicaid
utilization data relating to such manufacturer's products,
pursuant to a State supplemental rebate agreement negotiated with
such manufacturer and approved by the federal government under
Section 1927 of the federal Social Security Act.
(d) The commission may enter into a written agreement with a
manufacturer to accept certain program benefits in lieu of
supplemental rebates, as such term is defined herein, only if:
(1) the program benefit yields savings that are at
least equal to the amount the manufacturer would have provided
under a state supplemental rebate agreement during the current
biennium as determined by such written agreement;
(2) the manufacturer posts a performance bond
guaranteeing savings to the state. If the savings are not achieved
in accordance with the written agreement, the manufacturer will
forfeit the bond to the state less any savings that were achieved;
and
(3) the program benefit is in addition to other program
benefits currently offered by the manufacturer to recipients of
medical assistance or related programs.
(e) For the purposes of this section, a program benefit may
mean disease management programs authorized under this title, drug
product donation programs, drug utilization control programs,
prescriber and beneficiary counseling and education, fraud and
abuse initiatives, and other services or administrative
investments with guaranteed savings to a program operated by a
health and human service agency.
(f) Other than as required to satisfy the provisions of this
section, such program investments shall be deemed an alternative
to, and not the equivalent of, supplemental rebates and shall be
treated in the State's submissions to the federal government
(including, as appropriate, waiver requests and quarterly Medicaid
claims) so as to maximize the availability of federal matching
payments.
(g) Agreements by the commission to accept program benefits
as defined by this section:
(1) may not prohibit the commission from entering into
similar agreements related to different drug classes with other
entities;
(2) shall be limited to a time period expressly
determined by the commission; and
(3) may only cover products that have received approval
by the Federal Drug Administration at the time of the agreement, and
new products approved after the agreement may be incorporated only
under an amendment to the agreement.
(h) For the purposes of this section, the commission may
consider a monetary contribution or donation to the arrangements
described in subsection (b) for the purpose of offsetting
expenditures to other state healthcare programs, but which funding
shall not be used to offset expenditures for covered outpatient
drugs as defined by 42 USC Section 1396(k)(5) under the vendor drug
program. An arrangement under this subsection may not yield less
than the amount the state would have benefitted under a
supplemental rebate. The commission may consider an arrangement
under this section as satisfying the requirements related to
Section 531.072(b)."